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Terminated

The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.

FDA Recall Z-0225-2015 · Posted 2014-11-18

Recalling FirmMedacta Usa
Recall StatusTerminated
Product CodeMAX
Date Initiated2014-10-21
Date Terminated2016-03-14
Product Quantity32 oblique handles

Reason for Recall

The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

Firm Action

Medacta sent an URGENT MEDICAL DEVICE RECALL letter dated October 21, 2014 were via e-mail to all sales representatives and distributors. The letters included instructions for the sales represetantives and distributors to: 1) check their inventory for the recalled devices; 2) immedaitely sequester the recalled devices and do not use them during surgery; 3) if the devices have been further distributed, inform them of the recall; and, 4) replacement devices will be provided. Customers with questions can contact Medacta USA at 805-910-6511.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110927MECTALIFMedacta International · 2011-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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